Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

Pharm Analysis 2 > Quiz #1 > Flashcards

Quiz #1 Flashcards

1
Q

Totality of characteristics or features of a product that bears on its capacity to satisfy stated or implied needs

A

Quality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

CGMP meaning

A

Current Good Manufacturing Practice

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

CGMP was promulgated by the US FDA in _____ and finalized on ______.

A

1963 & 1979

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

CGMP was established _______

A

To ensure that minimum standards are met for a drug product quality

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Sum total of organized arrangement and has objective in assuring quality required by their intended use.

A

Quality assurance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Helps to identify and prepare necessary SOP’s relative control quality.

A

Quality Assurance Department Functions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

SOP meaning

A

Standard Operation Procedures

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Determine if operations have adequate systems, facilities and written procedures

A

Audit and Quality Monitoring

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Assures policies are followed inept to economic issues associated with manufacturing and distribution of product.

A

Audit and Quality Monitoring

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Cooperate with regulatory agencies and final authority for product acceptance or rejection.

A

Audit and Quality Monitoring

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

This is a part of CGMP concerned with sampling, specifications, testing, organization, documentation, and release until quality is judged satisfactory.

A

Quality control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

3 functions of quality control (TIM)

A
  1. Testing and acceptance of any high quality raw materials.
  2. IP tests against criteria
  3. Monitors environmental conditions
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

RMQC

A

Raw Material Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

IPQC

A

In Process Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

FPQC

A

Future Product Quality Control

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Document that specifies all the tests TO BE CONDUCTED on a product.

A

Monograph

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Document with the results of all TESTS CONDUCTED on material to show compliance or noncompliance.

A

Certificate Analysis

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

This is generated to explain in detail the behind a procedure and proper sequence of STEP TO BE DONE.

A

SOP/ Standard Operation Procedure

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

SOP includes:

A

Record Keeping
Facilitate recall
Step by step method

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

It is finite number of objects selected from batch of a product or from a population.

A

Sample

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

This is take from a population and represent the whole batch from where it is taken.

A

Sample

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

What is Accuracy or Accurate?

A

Closeness of test results to the true value.
Example: result is 3.5 but the answer is 3.3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

Degree of agreement among individual test results when the method is applied repeatedly to multiple samplings of a homogenous sample.

A

Precision

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

It involves Class 1-4

A

Analytical Balances

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

It is a class of A.B where they recommended for balances using optical or electrical methods for accurately weighing quantities below 20 mg.

A

Class 1.1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

Class of A.B with high precision standard for calibration, used for weighing accurately quantities below 20 mg.

A

Class 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

Class of A.B where used for qty greater than 20 mg

A

Class 2

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

It is classes of A.B where they used with moderate precision laboratory chances.

A

Class 3 & 4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

Class of A.B where used for qty greater than 50 mg

A

Class 3

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

Class of A.B where used for qty greater than 100 mg

A

Class 4

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

What are the 3 kinds of defects?

A

MINOR
MAJOR
CRITICAL

32
Q

It is kind of defects where it makes the product dangerous or not viable for its intended use

A

Critical Defect

33
Q

It is kind of defect where they may effect the function of an object and therefore, may render the product useless.

A

Major Defect

34
Q

Kind of defect where it’s not likely to reduce materially the viability of the product of its intended purpose but represents a departure from established std having little bearing on the effective use of the product.

A

Minor Defect

35
Q

RMQC includes these tests:

A

ID tests
Purity tests
Limit tests
Physical tests

36
Q

Debasement f article and involves contamination

A

Adulteration

37
Q

What are the 5 classification of Adulteration.

A

Sophistication
Spoilage
Substitution
Admixture
Deterioration

38
Q

True adulteration and addition of inferior material to any article

A

Sophistication

39
Q

Example of Sophistication

A

Teatree oil– olive oil and Safflower—saffron

40
Q

Entirely different is used in place of the requested and almost the same with sophistication

A

Substitution

41
Q

Example of Substitution

A

Japanese anise- Star anise

42
Q

Addition of an article to another through accident, ignorance and carelessness

A

Admixture

43
Q

Quality if destroyed by action of microorganism

A

Spoilage

44
Q

Example of Spoilage

A

Sarsapilla with soil

45
Q

Quality impaired by abstraction, destruction of valuable due to environmental agents, insects etc.

A

Deterioration

46
Q

What are the methods in Identification Test (ID)

A

Chemical Method and Instrumental method

47
Q

It is a method under ID test where there is change in color precipitation and evolution of gas

A

Chemical method

48
Q

It is a method under ID tests where there is IR spec, UV-vis speC, HPLC, and nuclear magnetic resonance

A

Instrumental method

49
Q

Vibration, compared to standard

A

IR spec

50
Q

Excitation: absorbed and transmitted light

A

UV-vis speC

51
Q

Retention factor

A

HPLC

52
Q

HPLC meaning

A

High Performance Liquid Chromatography

53
Q

Amount of magnetic signal or field

A

Nuclear magnetic resonance

54
Q

TEST FOR PURITY includes:

A

Monograph Assay

55
Q

Includes titration and Instrument method (GC & HPLC)

A

Monograph Assay

56
Q

GC meaning

A

Gas chromatography

57
Q

LIMIT TEST includes:

A

Gross, Biological and Chemical Impurities

58
Q

Insoluble matter and dirt

A

Gross Impurities

59
Q

o Microorganism (natural products)
o Cell debris
o Degredation products

A

Biological Impurities

60
Q

Trace metals

A

Chemical Impurities

61
Q

AgNO3 -> AgCl

A

Chloride

62
Q

BaCL2 -> BaSO4

A

Sulphates

63
Q

Diethyldithiocarbamate (vis-spec 535-45 mm)

A

Arsenic

64
Q

Flame spectroscopy

A

Sodium and Calcium

65
Q

Ammonium thocyanate -> blood red complex

A

Iron

66
Q

H2S -> black

A

Heavy Metals

67
Q

Under chemical impurities what are the exceptions elements?

A
  • Zinc – white (znow)
  • Cadnium – yellow (yellow cad)
  • Tin – Orange (can)
  • Mn – pink (man wear ink)
68
Q

PHYSICAL TESTS INCLUDES 6:

A

Specific Gravity, Solubility Test, Refractive Index, Optical activity, Melting Point, and Boiling Point

69
Q

Ratio of the wt of the sample or wt of standard water

A

Specific gravity

70
Q

Includes Pyconometer and Westphal Balance

A

Specific Gravity

71
Q

Dissolution of the compound in a suitable solvent

A

Solubility Test

72
Q

Under Refractive Index is ___

A

Abbe refractometer

73
Q

Bending of light and ratio of the velocity of light in air and velocity of light in a sample

A

Abbe refractometer

74
Q

Under optical activity is ____

A

Polarimeter

75
Q

Measures the angle of optical rotation of a plane polarized light in passing thru a sample material

A

Polarimeter

76
Q

The temperature at which the vapor pressure of a liquid is equal to the atmospheric pressure.

A

Boiling Point

Pharm Analysis 2 (1 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions